All the aspects of Quality Assurance in the development and life cycle of drugs are reviewed.
The students will have a clear overview of the different GxP Quality systems, and other international standards in the field of drug development. Through exercises and examples they will understand the utility of quality systems and how they must be applied to improve quality of operations an organization and to fulfill regulatory requirements.
As an introduction, the principles of quality assurance in the field of healthcare and drug development are depicted. Then, the international standard ISO17025 is reviewed in details to give a complete overview of a quality system with organizational and technical requirements.
The next chapters cover the different GxP standards:
-GLP (good laboratory practices) for the pre-clinical studies
-GCP (good clinical practices) and GCLP (good clinical laboratory practices) for the clinical studies
-GMP (good manufacturing practices and GDP (good distribution practices) for drug production and distribution)
Finally, a chapter is dedicated to the concept of validation in the broad sense of the term, to cover all the topics concerned by qualification or validation needs (equipment, process, methods, IT systems….)
Chapitre 1 : Introduction to quality assurance
Chapitre v2 : ISO17025
Chapitre 3 : GLP
Chapitre 4 : GCP/GCLP/ISO15189/CLIA
Chapitre 5 : GMP/GDP
Chapitre 6 : validations
Practice of GXP activities
Presentation by students of document analysis
Written exam in the form of open questions.
ISO17025 and ISO15189
Monographs GLP OCDE
GCP ICH E6
GCLP EMA
Eudralex Volume 4
GDP EU